Edwards Lifesciences Outlines Growth Strategy At Annual Investor Conference

NEW YORK, Dec. 8, 2014 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, will discuss the company's strategy for longer-term growth, provide an update on its technology pipeline and share its financial guidance for 2015 during its annual investor conference today in New York City.  Edwards will also reaffirm its current 2014 total sales and earnings guidance, which includes diluted earnings per share of $3.33 to $3.39, excluding special items. 

"We expect 2015 to be another year of attractive organic sales growth for Edwards Lifesciences as we continue executing our focused innovation strategy to provide breakthrough therapies for patients in need," said Michael A. Mussallem, chairman and CEO.  "Sales of our market-leading technologies, together with greater operating leverage, position us for strong financial performance."

During the conference, Edwards' management will present the company's financial guidance for 2015.  Edwards expects sales of $2.3 billion to $2.5 billion, which at current foreign exchange rates reflects an estimated $90 million unfavorable impact. Underlying sales growth is expected to be 7 to 11 percent. Additionally, the company expects a gross profit margin of approximately 75 percent, a diluted EPS range of $3.90 to $4.10, and free cash flow of $375 million to $425 million, with all guidance excluding special items. "We also expect to continue our strategic investment in research and development of 15 to 16 percent of sales in 2015, which positions Edwards for longer term growth, and enables us to serve more patients and drive greater shareholder value," said Mussallem.

Among the specific topics to be discussed at today's event are:

• Transcatheter Heart Valves – Edwards is well positioned to continue strengthening its global leadership by providing innovative, best-in-class therapies.  Newer devices with additional sizes, improving economics, and increasing awareness of this compelling alternative to traditional therapy, are expected to broaden the availability of transcatheter technology and double sales of global TAVR procedures to more than $3 billion in 2019.  Edwards will update its product development timelines including the now anticipated U.S. launch of SAPIEN 3 for high risk patients early in 2016.
  
  Edwards expects to generate THV sales of $1.0 billion to $1.1 billion in 2015, representing a 15 to 25 percent underlying growth rate, even as competition intensifies.  
  
  
• Surgical Heart Valve Therapy – Substantial investments in new technologies coupled with an aging global population are expected to drive continued growth of Edwards' leading surgical heart valve platform over the longer term, even as the adoption of transcatheter heart valves is expected to moderate its growth rate.  At the conference, the company will discuss its new product strategies including the planned 2016 U.S. introduction of its minimally invasive EDWARDS INTUITY Elite valve, new tissue treatment technology, and expanded surgical options for younger patients.
  
  Edwards expects to generate Surgical Heart Valve Therapy sales, which includes surgical heart valves and cardiac surgery products, of $780 million to $820 million in 2015, representing a 1 to 3 percent underlying growth rate. Underlying sales of surgical heart valve products alone are expected to grow 3 to 5 percent.  
  
  
• Critical Care – In 2015, Edwards expects to continue building upon its global leadership in hemodynamic monitoring by expanding the benefits of Enhanced Surgical Recovery (ESR) to a broader patient population with its ClearSight noninvasive platform.  ESR represents an underpenetrated opportunity to help clinicians make more informed fluid management decisions for their patients, which can result in clinical and economic benefits. 
  
  Edwards expects to generate Critical Care sales of $520 million to $570 million in 2015, representing a 2 to 4 percent underlying growth rate.
  
  Edwards announced today that Katie Szyman will be joining the company at the start of 2015 as corporate vice president, critical care. She comes to Edwards from Medtronic, where she has held a number of leadership roles during the last 20 years, including senior vice president, channel management, and group president of Medtronic Diabetes.  "We are very pleased to welcome Katie to Edwards, and are confident that her passion for helping patients and her extensive leadership experience will be valuable to our critical care organization," said Mussallem.
  
  
• Edwards is continuing to make progress in its FORTIS transcatheter mitral valve program.  Patients in Europe and Canada continue to be enrolled in prospective feasibility studies, and a feasibility study in the U.S. is expected to commence in 2015.  Although the journey to commercialization may be long and durable success will require significantly more experience, the company continues to believe transcatheter mitral technologies have the potential to address a large patient need.

Edwards is also announcing two strategic investments. First, the company made a structured investment in CardioKinetix, Inc., a privately held medical device company pioneering a catheter-based treatment for heart failure.  This transaction increases Edwards' existing minority interest in CardioKinetix and provides an option to purchase the remaining outstanding shares for a future payment, plus additional milestone payments based on future regulatory and reimbursement approvals.  In the second investment, the company acquired intellectual property that broadens its transcatheter mitral valve development efforts.  Additional details of both investments were not disclosed. 

In addition to Mr. Mussallem, other members of Edwards' management team presenting at the conference include:

Donald E. Bobo, Jr., Corporate Vice President, Heart Valve Therapy;
Scott B. Ullem, Chief Financial Officer; and
Larry L. Wood, Corporate Vice President, Transcatheter Heart Valves.

Guest Speakers to Provide Clinical Perspective
Also speaking at the conference are Brian K. Whisenant, MD, Intermountain Heart Institute Cardiology, Michael M. Borger, MD, PhD, NewYork/Presbyterian/Columbia University, and Professor Monty G. Mythen, University College London Hospitals.

Webcast Information
The Edwards Lifesciences 2014 Investor Conference can be accessed via live webcast at http://ir.edwards.com/2014-investor-conference.cfm beginning at 9:00 a.m. Eastern Time on December 8, 2014.  The webcast will also be archived on the Edwards Web site after the conference concludes.

About Edwards Lifesciences 
Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring that enable them to save and enhance lives. Additional company information can be found at www.edwards.com.

This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.  These forward-looking statements can sometimes be identified by the use of words such as "may," "will," "should," "anticipate," "believe," "plan," "project," "estimate," "expect," "intend," "guidance," "outlook," "optimistic," "aspire," "confident"  or other forms of these words or similar expressions and may include, but are not limited to, Mr. Mussallem's statements; the Company's 2014 and 2015 financial goals or expectations for sales and sales growth, gross profit margin, earnings per share, R&D expense, free cash flow and other financial expectations; strategies to maintain leadership positions and lead in the development of new technologies such as TMVR; and expectations regarding the development and introduction of new products, indications and technologies (including expected timelines and outcomes of clinical trials, regulatory approvals, and first-in-human trials).  Forward-looking statements are based on estimates and assumptions made by management of the Company and are believed to be reasonable, though they are inherently uncertain and difficult to predict.  Our forward-looking statements speak only as of the date on which they are made and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement.  If the Company does update or correct one or more of these statements, investors and others should not conclude that the Company will make additional updates or corrections.

Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements.  Factors that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements include unexpected changes or developments in opportunities for the Company's transcatheter valve programs  (THV) and the ability of the Company to continue to lead in the development of its product categories; the rate of growth in THV procedures globally;  the Company's success in developing new products; uncertainties associated with the timing and extent of regulatory approvals, expanded indications and reimbursement levels for our products, particularly THV; unexpected quality or manufacturing issues; reimbursement for the Company's products; the impact of competitive products; changes in currency exchange rates; actions by the U.S. Food and Drug Administration and other regulatory agencies; and other risks detailed in the Company's filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2013. 

To supplement the consolidated financial results prepared in accordance with Generally Accepted Accounting Principles ("GAAP"), the Company uses non-GAAP financial measures. The Company uses the term "underlying" when referring to non-GAAP sales information, which excludes discontinued and acquired products and foreign exchange fluctuations, and "excluding special items" and "adjusted" to also exclude gains and losses and sales return reserve from special items such as significant investments, litigation, and business development transactions. Guidance for sales and sales growth rates is provided on an "underlying" basis, and projections for diluted earnings per share, gross profit margin, and free cash flow are also provided on the same non-GAAP (or "excluding special items") basis due to the inherent difficulty in forecasting such items. Management does not consider the excluded items part of day-to-day business or reflective of the core operational activities of the Company as they result from transactions outside the ordinary course of business. Management uses non-GAAP financial measures internally for strategic decision making, forecasting future results and evaluating current performance. By disclosing non-GAAP financial measures, management intends to provide investors with a more meaningful, consistent comparison of the Company's core operating results and trends for the periods presented. These non-GAAP financial measures are used in addition to and in conjunction with results presented in accordance with GAAP and reflect an additional way of viewing aspects of the company's operations that, when viewed with its GAAP results, provide a more complete understanding of factors and trends affecting the company's business. These non-GAAP measures should be considered as a supplement to, and not as a substitute for, or superior to, the corresponding measures calculated in accordance with generally accepted accounting principles. Non-GAAP financial measures are not prepared in accordance with GAAP; therefore, the information is not necessarily comparable to other companies. The Company is not able to provide a reconciliation of projections for underlying sales and sales growth or projected gross profit margin, projected earnings per share guidance and projected free cash flow, excluding special items, to expected reported results due to the unknown effect, timing and potential significance of special charges or gains, and management's inability to forecast foreign currency changes and charges associated with future transactions and initiatives.

Edwards, Edwards Lifesciences, the stylized E logo, CENTERA, ClearSight, EV1000, EDWARDS INTUITY Elite, Edwards SAPIEN, Edwards SAPIEN XT, SAPIEN, SAPIEN 3, GlucoClear, and GLX are trademarks of Edwards Lifesciences Corporation.

Free cash flow is defined as cash flow from operating activities less capital expenditures.

"Underlying" amounts are non-GAAP and in this press release assume a constant foreign currency rate in 2014.

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SOURCE Edwards Lifesciences Corporation

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